Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

NCT01633931 | Unknown

• 1 other identifier: PR0038
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

• Change in major scoliotic curve magnitude

  Measured in degrees

  Change from baseline to 36 months postoperative

• Number and Types of Adverse Events

  Operative through 36 months postoperative

Secondary Outcomes (6)

• Radiographic evaluation coronal balance compared to baseline

  Change from baseline to 36 months postoperative

• Radiographic evaluation sagittal balance compared to baseline

  Change from baseline to 36 months postoperative

• Percent of patients indicated for surgical spine fusion

  Change from baseline to 36 months postoperative

• Quality of life assessment via SRS-30 questionnaire

  Change from baseline to 36 months postoperative

• Comparison of Rib Hump prominence

  Change from baseline to 36 months postoperative

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Adolescent Idiopathic Diagnosis

You may qualify if:

• Diagnosis of Adolescent Idiopathic Scoliosis
• Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
• Skeletally immature (Risser Sign 0, 1, 2, or 3)
• In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
• Age between 10 and 15
• Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
• Candidate for surgical implantation of spinal instrumentation
• Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
• Must sign informed consent to permit the use of personal health data

You may not qualify if:

• Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
• Patients who require an MRI following implantation
• Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
• Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
• History of previous surgical treatment for AIS

Sponsors & Collaborators

• Ellipse Technologies, Inc.: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Pokfulam, Hong Kong

Location

Study Officials

• Behrooz Akbarnia, MD

  San Diego Center for Spinal Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2018
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

HK (1)